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    K Number
    K112408
    Device Name
    POLY-CHEM 90 ISE MODULE
    Manufacturer
    POLYMEDCO, INC.
    Date Cleared
    2011-11-04

    (74 days)

    Product Code
    CEM, CGZ, JGS
    Regulation Number
    862.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMEDCO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Poly-Chem 90 ISE Module is for the quantitative in vitro measurement of sodium, potassium, and chloride in human serum on the Poly-Chem 90 clinical chemistry analyzer. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
    Device Description
    Poly-Chem 90 ISE Module is for the quantitative in vitro measurement of the level of sodium, potassium and chloride in human serum on the Poly-Chem 90 clinical chemistry analyzer. The ISE module measures sodium, potassium and chloride using ion selective electrode technology.
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    K Number
    K110818
    Device Name
    POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS
    Manufacturer
    POLYMEDCO, INC.
    Date Cleared
    2011-09-08

    (168 days)

    Product Code
    CIX, CDQ, CGX, CIC, KHS
    Regulation Number
    862.1035
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMEDCO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Poly-Chem 90 Albumin test system is an in vitro diagnostic procedure intended to measure the albumin concentration in human serum on the Poly-Chem 90 analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. The Poly-Chem 90 BUN test system is an in vitro diagnostic procedure intended to measure urea nitrogen (an end-product of nitrogen metabolism) in human serum on the Poly-Chem 90 analyzer. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. The Poly-Chem 90 Calcium test system is an in vitro diagnostic procedure intended to measure the total calcium level in human serum on the Poly-Chem 90 analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). The Poly-Chem 90 Carbon Dioxide test system is an in vitro diagnostic procedure intended to measure bicarbonate/carbon dioxide in human serum on the Poly-Chem 90 analyzer. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. The Poly-Chem 90 Creatinine test system is an in vitro diagnostic procedure intended to measure creatinine levels in human serum on the Poly-Chem 90 analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
    Device Description
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    K Number
    K111143
    Device Name
    POLY-CHEM 90 TOTAL BILIRUBIN
    Manufacturer
    POLYMEDCO, INC.
    Date Cleared
    2011-09-01

    (132 days)

    Product Code
    CIG, DAT, REG
    Regulation Number
    862.1110
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMEDCO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Poly-Chem 90 Total Bilirubin is for the quantitative in vitro measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. Measurements of the level of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
    Device Description
    Poly-Chem 90 Total Bilirubin is for the quantitative in vitro measurement of the level of total bilirubin in human serum on the Poly-Chem 90 clinical chemistry analyzer. The test methodology is a colorimetric method based on that described by Jendrassik and Grof (1938). Total bilirubin is determined in the presence of caffeine, which releases albumin bound bilirubin, by the reaction with diazotized sulphanilic acid.
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    K Number
    K100550
    Device Name
    POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
    Manufacturer
    POLYMEDCO, INC.
    Date Cleared
    2010-09-28

    (214 days)

    Product Code
    LBS, CDT, CHH, MRR
    Regulation Number
    862.1475
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMEDCO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Poly-Chem 90 Direct HDL-Cholesterol test system is an in vitro diagnostic procedure intended to measure high density lipoproteins quantitatively in human serum on the Poly-Chem 90 analyzer. HDL Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various other liver and renal diseases, and for the assessment for the risk of developing cardiovascular disease. The Poly-Chem 90 Direct LDL-Cholesterol test system is an in vitro diagnostic procedure intended to measure low density lipoprotens quantitatively in human serum on the Poly-Chem 90 analyzer. LDL Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various other liver and renal diseases, and for the assessment for the risk of developing cardiovascular disease. The Poly-Chem 90 Cholesterol test system is an in vitro diagnostic procedure intended to measure cholesterol quantitatively in human serum on the Poly-Chem 90 analyzer. Cholesterol measurements are used in the diagnosis and treatment of lipid disorders, lipoprotein metabolism disorders and atherosclerosis. The Poly-Chem 90 Triglycerides test system is an in vitro diagnostic procedure intended to measure triglyceride quantitatively in human serum on the Poly-Chem 90 analyzer. Triglycerides measurements are used in the diagnosis and treatment of disease involving lipid metabolism and various endocrine disorders e.g. diabetes mellitus, nephrosis and liver obstruction.
    Device Description
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    K Number
    K090703
    Device Name
    POLY-CHEM 90 GLUCOSE
    Manufacturer
    POLYMEDCO, INC.
    Date Cleared
    2009-10-20

    (217 days)

    Product Code
    CFR, CIT, CJE
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMEDCO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Poly-Chem 90 glucose test system is an in vitro diagnostic procedure intended to measure qlucose quantitatively in human serum and plasma on the Poly-Chem 90 analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypodycemia. and idiopathic glycemia, and of the pancreatic isle cell carcinoma. The Poly-Chem 90 ALP test system is an in vitro diagnostic procedure intended to measure alkaline phosphatase quantitatively in human serum and plasma on the Poly-Chem 90 analyzer. Measurements of alkaline phosphatase are of use in the diagnosis, treatment, and investigation of hepatobiliary disease and in bone disease associated with increased osteoblastic activity. Alkaline phosphatase is also used in the diagnosis of parathyroid and intestinal disease. The Poly-Chem 90 AST test system is an in vitro diagnostic procedure intended to measure aspartate aminotransferase (AST) quantitatively in human serum and plasma on the Poly-Chem 90 analyzer. AST measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
    Device Description
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    K Number
    K061944
    Device Name
    POLY-CHEM CREATININE
    Manufacturer
    POLYMEDCO, INC.
    Date Cleared
    2006-11-03

    (116 days)

    Product Code
    JFY
    Regulation Number
    862.1225
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMEDCO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Poly-Chem Creatinine test is intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
    Device Description
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    K Number
    K053553
    Device Name
    NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL
    Manufacturer
    POLYMEDCO, INC.
    Date Cleared
    2006-03-09

    (79 days)

    Product Code
    DCF, JJX
    Regulation Number
    866.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMEDCO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NycoCard U-Albumin is intended to measure by immunochemical techniques the albumin (a plasma protein) in urine. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases. NycoCard U-Albumin Control consists of two control materials based on human urine and is intended to be used to confirm the efficacy of the NycoCard U-Albumin reagents and correct performance of the test.
    Device Description
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    K Number
    K041408
    Device Name
    POLYMEDCO OC AUTO MICRO 80 FOB TEST
    Manufacturer
    POLYMEDCO, INC.
    Date Cleared
    2004-10-21

    (147 days)

    Product Code
    OOX, 00X
    Regulation Number
    864.6550
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMEDCO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Polymedco OC Auto Micro 80 Analyzer and OC Auto Micro FOB Test are designed to be used together as an immunological test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is useful for the determination of gastrointestinal (GI) bleeding, found in a number of gastrointestinal (GI) disorders, e.g., colitis, polyps, and colorectal cancer. The OC Auto Micro FOB Test is recommended for use in - 1. Routine physical examinations - 2. Monitoring for bleeding in patients - 3. Screening for colorectal cancer or gastrointestinal bleeding
    Device Description
    The Polymedco OC Auto Micro 80 Analyzer and OC Auto Micro FOB Test are designed to be used together as an immunological test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories.
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    K Number
    K041297
    Device Name
    POLYMEDCO OC LIGHT FOBT TEST
    Manufacturer
    POLYMEDCO, INC.
    Date Cleared
    2004-08-12

    (90 days)

    Product Code
    KHE
    Regulation Number
    864.6550
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMEDCO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Polymedco OC Light FOB test is an immunological test intended for the detection of fecal occult blood in feces by professional laboratories and physician office labs. The test is useful for the determination of gastrointestinal (GI) bleeding, found in a number of disorders, e.g., diverticulitis, colitis, polyps, and colorectal cancer. The OC Light test is recommended for use in 1) routine physical examinations 2) monitoring for bleeding in patients 3) screening for colorectal cancer or gastrointestinal bleeding
    Device Description
    The Polymedco OC Light FOB test is an immunological test intended for the detection of fecal occult blood in feces.
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    K Number
    K033706
    Device Name
    POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS
    Manufacturer
    POLYMEDCO, INC.
    Date Cleared
    2004-02-04

    (70 days)

    Product Code
    LPS, JIT, JJX
    Regulation Number
    862.1377
    Why did this record match?
    Applicant Name (Manufacturer) :

    POLYMEDCO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Polymedco Homocysteine Test is intended for the quantitative in vitro determination of total homocysteine in serum and plasma on automated clinical chemistry analyzers. This device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The Homocysteine Calibrators are a device intended for medical purposes for use with the Polymedco Homocysteine assay to establish points of reference that are used in determination of values in the measurement of homocysteine in human serum or plasma. The Homocysteine Controls are intended for use as an assayed quality control serum to monitor the precision and accuracy of the laboratory testing procedures for total homocysteinc.
    Device Description
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